NCT01122329已完成4 期
A Single-site Positron Emission Tomography (PET) Study of the Cerebral Metabolic Effects of AC-1202 (Axona®) Treatment in Mild-to-Moderate Alzheimer's Disease (AD)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Regional cerebral blood flow (rCBF)
研究概览
简要总结
This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable AD (NINDS-ADRDA criteria(32))
- •Age 50 - 90 (inclusive)
- •MMSE range: 10 to 28
- •Participants may be taking medications for AD, provided that the dose of these medications has been stable for > 90 days
- •Proficiency in English to be able to perform cognitive tests
- •A caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit.
排除标准
- •Inability for any reason to undergo PET/CT scans
- •Previous treatment with AC-1202
- •Allergic to milk or soy
- •Presence of neurodegenerative disease other than AD
- •History of stroke or other injury that could result in cognitive impairment
- •Psychiatric disorder
- •Diabetes mellitus
- •Recent (<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition
- •Irritable bowel syndrome (IBS) or other gastrointestinal conditions that could interfere with treatment compliance
- •Any factor deemed by the investigator to be likely to interfere with study conduction
结局指标
主要结局
Regional cerebral blood flow (rCBF)
时间窗: 45 days after initation of treatment with Axona®
次要结局
- Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition(45 days after initiation of treatment with Axona®)
- To examine the effect of AC-1202 on cognition(45 days after initiation of treatment with Axona®)
研究者
Joshua Grill, PhD
Assistant Professor
University of California, Los Angeles
研究点 (4)
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